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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K943416
Device Name DELFIA NEONATAL THYROXINE KIT
Applicant
Wallac OY
P.O. Box 10
Sf-20101 Turku
Finland,  FI
Applicant Contact GUNNEL LAADSONEN
Correspondent
Wallac OY
P.O. Box 10
Sf-20101 Turku
Finland,  FI
Correspondent Contact GUNNEL LAADSONEN
Regulation Number862.1700
Classification Product Code
CDX  
Date Received07/15/1994
Decision Date 03/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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